Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

Chronic Refractory Neuropathic Pain Clinical Trial

— PRECISION  

Official title:

Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208999
• Other study ID #: 2011045
• Secondary ID: 913018
• Status: Completed
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2019
• Source: Cemka-Eval
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessing the long-term efficacy, complications, revision rates and final explantation of the device

Description:

Longitudinal study with a follow-up of 2 years in patients implanted with the Precision neurostimulator.

This study will describe the characterisrics of the patients, of the implantation and will assess the long-term efficacy, complications, revision rates and final explantation of the device

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary implantation or reimplantation)

Exclusion Criteria:

• Refusal of patient

• Patient whose long-term monitoring will not be possible

Related Conditions & MeSH terms

• Chronic Refractory Neuropathic Pain
• Ischemic Peripheral Pain
• Neuralgia

Intervention

Device:
• Neurostimulator Precision
All patients included must have been implanted with the neurostimulator Precision

Locations

Country	Name	City	State
France	Hospitals implanting the neurostimulator Precision	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Cemka-Eval	Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.	Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.	From baseline until the end of the study at 24 months.
Primary	Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.	The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.	From baseline until the end of the study at 24 months.
Secondary	Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale	Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for: pain at the present time; usual pain over the past 8 days; the most severe pain in the last 8 days	From baseline until the end of the study at 24 months
Secondary	Patients' Opinion on the Evolution of Pain	- Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.	From baseline until the end of the study at 24 months
Secondary	Evolution of the Use of Other Pain Treatments	Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)	From baseline until the end of the study at 24 months
Secondary	Evolution of Quality of Life (SF-12) - Physical Score	Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical "quality of life.	From baseline until the end of the study at 24 months
Secondary	Patients' Willingness to Restart the Treatment	Patients' willingness to restart the treatment at 12 months and at 24 months.	From baseline until the end of the study at 24 months
Secondary	Percentage of Patients With Anxiety and Depression Disorders	Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.	From baseline until the end of the study at 24 months
Secondary	Evolution of Quality of Life (SF-12) - Mental Score	Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental "quality of life.	From baseline until the end of the study at 24 months
Secondary	Evolution of the Use of Level 3 Analgesics	Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients	From baseline until the end of the study at 24 months